Associate Principal Scientist, Regulatory Affairs
Core
Implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for biologics product franchises and preparing CMC sections for commercial or new biologics submissions.
Role type
Senior IC regulatory affairs scientist (biologics CMC)
Builds
Investigational New Drug Applications (IND), Biologics License Applications (BLA), and post-approval change documentation for biologics.
Domain
Biopharmaceuticals / Regulatory Affairs
Required skills
Biologics CMC regulatory strategy, IND/BLA/post-approval submission authoring, global regulatory guidelines (FDA/EMA/ICH), cross-functional collaboration, project management, scientific writing, regulatory compliance, problem-solving, stakeholder communication
Preferred skills
Antibody-drug conjugates (ADCs), combination products, complex dosage forms, Microbiology/Virology/Molecular Biology background
Technologies
eCTD
Responsibilities
Lead authoring of IND, BLA, and post-approval submissions; develop and execute global regulatory strategies; mentor Senior Scientists; participate in early/late development programs; resolve project issues through team collaboration.
Seniority
Senior, hands-on IC with mentorship responsibilities